Evaluation of Triple Antibiotic Paste Pulp Therapy Compared to Vitapex in Primary Molars.

NCT ID: NCT04547764

Last Updated: 2020-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2018-12-30

Brief Summary

The aim of the study was to compare the clinical and radiographic success of triple antibiotic paste (TAP) which includes (metronidazole, ciprofloxacin, and minocycline) and Vitapex (calcium hydroxide/iodoform paste) for root canal treatment of pulpally involved teeth.

Detailed Description

This study evaluated and compared the clinical and radiographic efficacy of non-instrumentation triple antibiotic paste pulp therapy (TAP) versus Vitapex pulpectomy in non-vital primary molars. Healthy 5 to 9 years old children with at least one non-vital primary molar were included in the study. molars were divided based on the subject's cooperation level and parental preference into two groups. In the first group, molars received TAP and in the second group, they received Vitapex pulpectomy followed by a stainless-steel crown. The TAP was freshly prepared and proportioned in equal parts by volume (metronidazole, minocycline, and ciprofloxacin=1:1:1) before the scheduled treatment appointment. The clinical and radiographic examination was performed by two calibrated and trained pediatric dentists at the pre-operative baseline and at the six- and 12-months follow-up visits.

Conditions

Dental Pulp Cavity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TAP group

Group Type: EXPERIMENTAL

triple antibiotic paste (TAP)

Intervention Type: DRUG

root canal treatment of pulpally involved teeth.

Vitapex group

Group Type: ACTIVE_COMPARATOR

Vitapex (calcium hydroxide/iodoform paste)

Intervention Type: DRUG

root canal treatment of pulpally involved teeth.

Interventions

triple antibiotic paste (TAP)

root canal treatment of pulpally involved teeth.

Intervention Type: DRUG

Vitapex (calcium hydroxide/iodoform paste)

root canal treatment of pulpally involved teeth.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Primary molars with at least one of the following signs and symptoms were eligible and were included in the study:

• badly decayed with signs of irreversible pulpitis,
• necrosis and chronic infection such as: pain or tenderness to percussion and palpation, abscess, fistula-opening, gingival swelling, grade II and greater pathological tooth mobility, evidence of periapical/bifurcation radiolucency,

All the teeth included, had physiological root resorption of less than one third of the root.

Exclusion Criteria

• Teeth showing radiographic evidence of excessive internal or external root resorption,
• perforated pulpal floor,
• excessive bone loss in furcation area involving the underlying tooth germ,
• non- restorable teeth were excluded from the study.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Abdulaziz University

OTHER

Sponsor Role: lead

Responsible Party

Heba sabbagh

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

heba sabbagh, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor, Department of Pediatric Dentistry King Abdulaziz University

Locations

King Abdulaziz University

Jeddah, Mecca Region, Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

067-16

Identifier Type: -

Identifier Source: org_study_id